Eligibility
The trial
Local study conflicts
- Co-enrolment to an observational study is permitted but not to another clinical trial of a medicinal product (CTIMP)
Inclusion Criteria:
All of:
- Age ≥ 18 years
- Clinically suspected or proven infection resulting in principal reason for acute illness
- SBP < 90 mmHg or MAP of < 65 mmHg
- Measured serum lactate of >2 mmol/L at the time of eligibility assessment (Nb The serum lactate should be measured 2 hours prior to determination of eligibility, where possible. Longer timeframes may be used and justified within the medical notes if, in the opinion of the investigator, the clinical status of the patient has not significantly improved in the time interval between lactate measurement and eligibility assessment. Lactate measurements more than 4 hours prior to eligibility assessment should not normally be used.)
- Hospital presentation within last 12 hours
Exclusion Criteria:
- >1500ml of intravenous fluid prior to screening
- Clinically judged to require immediate surgery (within one hour of eligibility assessment);
- Immediate (<1 hour) requirement for central venous access
- Chronic renal replacement therapy
- Known allergy/adverse reaction to norepinephrine
- Palliation / end of life care (explicit decision by patient/family/carer in conjunction with clinical team that active treatment beyond symptomatic relief is not appropriate)
- Previous recruitment in the trial
- Patients with permanent incapacity
- Pregnancy. All women of childbearing potential (WoCBP) must have a negative urine or serum pregnancy test result completed as part of screening requirements. WoCBP are defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Other primary causes of shock (e.g. suspected cardiogenic shock, haemorrhagic shock, etc)
- History or evidence of any other medical, neurological or psychological condition that would expose the subject to an undue risk of a significant Adverse Effect as determined by the clinical judgement of the investigator
- Participation in other clinical trials of investigational medicinal products
If the patient is eligible:
Explain that the patient may be eligible for [ study ].
Gain verbal agreement in principle before proceeding. Explain:
- Taking part in research is likely to improve the quality of their care
- Risks are carefully controlled - research is safe
- Explain the uncertainty that exists with respect to treatment of their condition;
- If they change their mind they can withdraw their participation at any point
Step-by-Step Guide to Recruitment:
In the working hours of the research team:
- Monday-Tuesday 07:30 – 20:00
Wednesday 07:30- 18:00 - Contact the EMROx research team on:
Mobile 0776818242
Tel 01865 222003
Bleep 6680
Page below here still under construction
Out of hours, weekends, and when the research nurse is not available:
Estimated time required to enroll
- Estimated time it will take to enroll a patient
Gather documentation
- How to obtain study document steps (forms; PIS; online PIS address)
- please paste any relevant images, e.g. of location
Formal consent process
- Steps to consent for patients with capacity, and how to record it
- Steps to consent for patients with no capacity, and how to record it
- where to store the records
- please paste any relevant images
Randomisation procedure
- Process of randomisation and recording of the outcome
- please paste any relevant images
Carrying out the intervention(s):
- [steps undertaken]
- documentation required in the patient notes
- Where any documentation required for the research time, and where it should be stored when completed
Disposition and follow-up:
If admitted:
- Any required information
If discharged:
- Any required information
- Any safety net advice
- What the follow-up plan will be